Skills Training for Adolescents With ADHD

NCT ID: NCT01019252

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-08-31

Brief Summary

The proposed study will be an initial test of a cognitive-behavioral intervention for adolescents with ADHD who are receiving medication treatment. It is based on our successful work with adults with ADHD who have been treated with medicines but are still having symptoms. It involves learning skills for organization and planning, attention, and mood.

Detailed Description

Attention Deficit Hyperactivity Disorder (ADHD) is a prevalent, distressing, and interfering condition that affects between 2% and 6% of adolescents. Although medications have been widely used as an effective treatment for many years as the sole treatment for ADHD, for many, clinically significant and interfering continued symptoms remain. Even after medication treatment, adolescents still experience residual ADHD symptoms and continue to have problems with inattention, concentration, disorganization, and other symptoms. However, research suggests that adolescents who have received some benefit from medication treatment can then experience further symptom reduction from participation in skills-based cognitive behavioral therapy. This study, adapted from a similar research study for adults with ADHD, will examine whether cognitive behavioral therapy (CBT) plus medication is more effective at treating ADHD than medication therapy alone in adolescents with ADHD.

Eligible participants will be randomly assigned to receive twelve weekly treatment sessions either immediately upon enrolling in the study or after a four-month waiting period. Questionnaires (that participants complete and ones that are done with an interviewer) will be used to assess participants' ADHD symptoms at study entry, after receiving the treatment, and at 4 month follow-up. Parents will have some involvement in therapy.

Note: participants must be able to come to Boston or another study location in the Greater Boston area for 4 assessment visits and 12 weekly therapy visits in order for participation to be feasible.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBT for ADHD first, then follow-up

Participants received Cognitive Behavioral Therapy following randomization.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.

Wait list first, then CBT for ADHD

Cross-over: Participants were assigned to a wait list after the initial assessment. They received Cognitive Behavioral Therapy after the 4 month assessment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioral Therapy (CBT)

Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.

Intervention Type: BEHAVIORAL

Other Intervention Names

Compensatory executive skills training

Eligibility Criteria

Inclusion Criteria

• Between the ages of 14 and 18
• In high school
• Principal Diagnosis of ADHD
• Stable prescription of Medications for ADHD
• ADHD has childhood onset
• Clinically significant ADHD symptoms

Exclusion Criteria

• Organic Mental Disorders
• Active Substance Abuse or Dependence
• Diagnosis of Conduct Disorder
• Mental Retardation or Pervasive Developmental Disorder
• Active Suicidality
• Previous History of CBT Therapy in adolescence
• Other condition interfering with consent or participation

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Steven A. Safren

Director, Behavioral Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven A. Safren, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Susan E Sprich, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Sprich SE, Safren SA, Finkelstein D, Remmert JE, Hammerness P. A randomized controlled trial of cognitive behavioral therapy for ADHD in medication-treated adolescents. J Child Psychol Psychiatry. 2016 Nov;57(11):1218-1226. doi: 10.1111/jcpp.12549. Epub 2016 Mar 17.

Reference Type: DERIVED

PMID: 26990084 (View on PubMed)

Other Identifiers

R34MH083063

Identifier Type: NIH

Identifier Source: secondary_id

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DDTR B4-TBI

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R34MH083063

Identifier Type: NIH

Identifier Source: org_study_id

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